Background/Purpose: Ixekizumab (IXE), an anti-interleukin-17A monoclonal antibody, has demonstrated superior efficacy to placebo in the treatment of patients with axial spondyloarthritis (axSpA) (Dougados M et al., Ann Rheum Dis, 2020; Deodhar A et al., Lancet, 2020). Previous studies have shown that the clinical presentation of women and men with ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA) may differ and influence treatment response (van der Horst-Bruinsma IE et al., Ann Rheum, 2019; Rusman T et al., Curr Rheumatol Rep, 2018). This analysis explored gender differences in baseline clinical characteristics among patients with AS and nr-axSpA using data from 3 randomized IXE controlled trials.

Methods: Baseline data for patients with AS before IXE treatment were integrated from COAST-V (biologic-naïve; NCT02696785) and COAST-W (prior tumor necrosis factor inhibitor inadequate response; NCT02696798). Baseline data for patients with nr-axSpA before IXE treatment from COAST-X (biologic-naïve; NCT02757352) were analyzed separately. Assessment of SpondyloArthritis International Society (ASAS) criteria was used to classify radiographic axSpA and nr-axSpA. The patients meeting the ASAS criteria for radiographic axSpA also fulfilled modified New York criteria for AS. Descriptive statistics were used to evaluate demographics and baseline clinical characteristics stratified by gender.

Results: Women were older at disease onset (AS: mean 30.1 [standard deviation 10.1]) vs. 26.5 [8.7] years; nr-axSpA: mean 32.0 [10.7] vs. 27.9 [7.7] years) and had a longer symptom duration (AS: mean 17.8 [12.2] vs. 16.7 [10.5] years; nr-axSpA: 12.3 [11.3] vs. 9.5 [9.2] years) than men. High disease activity, as measured by mean total Bath AS Disease Activity Index (BASDAI) score, was reported for both women (AS: 7.4 [1.5]; nr-axSpA: 7.4 [1.4]) and men (AS: 7.1 [1.4]; nr-axSpA: 6.9 [1.4]). Women scored higher than men on 5 of the 6 BASDAI questions, indicating that women reported more fatigue, spinal pain, peripheral joint symptoms, discomfort and tenderness, and morning stiffness. Women also reported more spinal pain at night vs. men (AS: 7.8 [1.7] vs. 7.4 [1.5]; nr-axSpA: 7.6 [1.8] vs. 7.0 [1.8]). Anterior uveitis was more common among men than women with AS (23.8% vs. 17.9%) and more common among women than men with nr-axSpA (15.2% vs. 7.1%). The prevalence of human leukocyte antigen B27 (HLA-B27) was higher among men vs. women (AS: 86.9% vs. 79.5%; nr-axSpA: 76.3% vs. 70.7%). C-reactive protein levels were higher in men compared to women with AS (17.4 [25.5] vs. 11.2 [12.8]) but similar in patients with nr-axSpA (men: 12.1 [17.4] vs. women: 12.3 [18.5]).

Conclusion: Baseline clinical characteristics differed between genders in both patients with AS and nr-axSpA. Women were older at disease onset, experienced longer symptom duration, had more peripheral joint symptoms, and had a lower prevalence of HLA-B27 than men.

a DMARDs included methotrexate, sulfasalazine, and hydroxychloroquine. Abbreviations: AS, ankylosing spondylitis; ASDAS, Ankylosing Spondylitis Disease Activity Score; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BASFI; Bath Ankylosing Spondylitis Functional Index; BMI, body mass index; CRP, C-reactive protein; DMARD, disease-modifying antirheumatic drug; HLA-B27, human leukocyte antigen B27; nr-axSpA, non-radiographic axial spondyloarthritis; NRS, numeric rating scale; Q, question; SD, standard deviation; SF-36 MCS: Medical Outcomes Study 36-Item Short Form Health Survey Mental Component Score; SF-36 PCS: Medical Outcomes Study 36-Item Short Form Health Survey Physical Component Score

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/gender-differences-in-baseline-clinical-characteristics-among-patients-with-ankylosing-spondylitis-and-non-radiographic-axial-spondyloarthritis-data-from-3-randomized-ixekizumab-controlled-trials/